阿普斯特治疗中重度斑块状银屑病有效性和安全性的Meta分析
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篇名: 阿普斯特治疗中重度斑块状银屑病有效性和安全性的Meta分析
TITLE:
摘要: 目的:系统评价阿普斯特治疗中重度斑块状银屑病的有效性和安全性。方法:计算机检索PubMed、Embase、Cochrane图书馆、维普、中国知网、中国生物医学文献数据库,收集阿普斯特或阿普斯特联合其他药物(试验组)对比安慰剂(对照组)治疗中重度斑块状银屑病的随机对照试验(RCT),筛选文献,提取资料后按Cochrane系统评价员手册5.1.0提供的偏倚风险评估工具进行质量评价后,采用Rev Man 5.3统计软件进行Meta分析。结果:共纳入7项研究,共计2 332例患者。Meta分析结果显示,试验组患者银屑病皮损面积和严重程度指数(PASI )下降 75%(PASI 75%)例数[OR=6.44,95%CI(4.90,8.45),P<0.000 01]、PASI 90%例数[OR=8.13,95%CI(4.65,14.22),P<0.000 01]、疾病严重度静态测量(sPGA)0或1例数 [OR=3.89,95%CI(3.00,5.05),P<0.000 01]、不良反应发生率[OR=1.87,95%CI(1.44,2.43),P<0.000 01]均显著多于或高于对照组。按试验组阿普斯特的不同剂量进行亚组分析,结果显示,试验组中使用20 mg PASI 75%例数[OR=4.72,95%CI(2.77,8.05),P<0.000 01]、30 mg PASI 75%例数[OR=7.05,95%CI(5.13,9.69),P<0.000 01]、20 mg PASI 90%例数[OR=4.27,95%CI(1.80,10.09),P=0.001]、30 mg PASI 90%例数[OR=11.11,95%CI(5.27,23.43),P<0.000 01]、20 mg sPGA 0或1例数[OR=2.82,95%CI(1.51,5.26),P=0.001]、30 mg sPGA 0或1例数 [OR=4.13,95%CI(3.10,5.50),P<0.000 01]、30 mg不良反应发生率[OR=1.94,95%CI(1.51,2.49),P<0.000 01] 均显著多于或高于对照组。两组患者严重不良反应发生率[OR=1.27,95%CI(0.77,2.07),P=0.35]、不良反应导致退出患者例数[OR=1.48,95%CI(1.00,2.20),P=0.05] 比较,差异均无统计学意义。结论:阿普斯特治疗中重度斑块状银屑病的疗效较好,且呈剂量依赖性;该药可提高患者的生活质量,但会增加其不良反应发生的风险。
ABSTRACT: OBJECTIVE: To evaluate the efficacy and safety of apremilast in the treatment of moderate-to-severe plaque psoriasis systematically. METHODS: Retrieved from PubMed, Embase, Cochrane Library, VIP, CNKI and CBM, RCTs about apremilast or apremilast combined with other drugs (trial group) versus placebo (control group) in the treatment of moderate- to-severe plaque psoriasis were collected. Meta-analysis was conducted by using Rev Man 5.3 statistical software after literature screening, data extraction and quality evaluation with bias risk evaluation tool of Cochrane System Evaluator Manual 5.1.0. RESULTS: Totally 7 studies were included, involving 2 332 patients. Results of Meta-analysis showed that case number of psoriasis assessment and severity index (PASI) decreased by 75% (PASI 75%) [OR=6.44,95%CI(4.90,8.45),P<0.000 01], PASI 90% [OR=8.13, 95%CI(4.65, 14.22), P<0.000 01] and sPGA 0 or 1 [OR=3.89,95%CI(3.00,5.05),P<0.000 01], the incidence of ADR [OR=1.87,95%CI(1.44,2.43), P<0.000 01] in trial group were significantly more or higher than control group. Subgroup analysis by apremilast dose showed that case number of 20 mg PASI 75% [OR=4.72,95%CI(2.77,8.05),P<0.000 01], 30 mg PASI 75% [OR=7.05,95%CI(5.13,9.69),P<0.000 01], 20 mg PASI 90% [OR=4.27,95%CI(1.80,10.09),P=0.001], 30 mg PASI 90% [OR=11.11,95%CI(5.27,23.43),P<0.000 01], 20 mg sPGA 0 or 1 [OR=2.82,95%CI(1.51,5.26),P=0.001], 30 mg sPGA 0 or 1 [OR=4.13,95%CI(3.10,5.50),P<0.000 01], the incidence of 30 mg ADR [OR=1.94,95%CI(1.51,2.49),P<0.000 01] in trial group were significantly more or higher than control group. There was no statistical significance in the incidence of serious ADR [OR=1.27,95%CI(0.77,2.07),P=0.35] or case number of ADR leading to withdrawal [OR=1.48,95%CI(1.00,2.20),P=0.05] between 2 groups. CONCLUSIONS: Apremilast is effective for moderate-to-severe plaque psoriasis in dose-dependent manner and improve the quality of life, but increase the incidence of ADR.
期刊: 2019年第30卷第10期
作者: 高珊,钟建桥,钟志容,李世琴,张富勇,王述蓉
AUTHORS: GAO Shan,ZHONG Jianqiao,ZHONG Zhirong,LI Shiqin,ZHANG Fuyong,WANG Shurong
关键字: 阿普斯特;中重度斑块状银屑病;疗效;安全性;Meta分析
KEYWORDS: Apremilast; Moderate-to-severe plaque psoriasis; Efficacy; Safety; Meta-analysis
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